skill_id: DOC-CHANGE-CONTROL version: 1.0.0 last_updated: 2026-01-04 applies_to: [Class A, Class B, Class C] jurisdiction: [FDA, EU MDR, Global] prerequisites: [REG-IEC62304, REG-ISO14971, DOC-INLINE]
Change Control Process
Purpose
Define controlled process for software changes: requests, impact analysis, approvals, verification, and configuration management in regulated contexts.
When to Apply
- Any change to safety-relevant software, requirements, design, tests, or configuration items.
- Defect fixes, updates, refactors, and dependency/SOUP updates.
Requirements (testable)
- Change Request: Document change description, rationale, items affected, and trace links (requirements, hazards, tests). Rationale: clarity.
- Impact Analysis: Assess safety, cybersecurity, interoperability, documentation, and submission impact (FDA/MDR). Rationale: risk-aware decisions.
- Approval: Obtain appropriate approvals (engineering + QA/RA) before implementation for safety-relevant changes. Rationale: governance.
- Verification: Define and execute verification/validation scope for the change; include regression tests. Rationale: assurance.
- Configuration Management: Update baselines, versions, and release notes; ensure traceability of change to artifacts. Rationale: auditability.
- Submission Considerations: Flag changes that may trigger regulatory submission/update; record decision. Rationale: compliance.
Recommended Practices
- Use templates for change requests with required fields.
- Include SBOM updates when dependencies change.
- Capture change risk level (minor/major) and tailor verification accordingly.
- Link commits/PRs to change request IDs.
Patterns
Change request (YAML):
CR-145:
description: Fix over-infusion timing edge case
rationale: observed jitter at low battery
affects: [REQ-62304-102, RISK-CTRL-19, TEST-410]
risk: major
submission_impact: no (reviewed QA/RA)
Verification entry:
Tests: TEST-410, TEST-411 rerun; new TEST-415 added for low-batt timing
Result: PASS
Anti-Patterns (risks)
- Implementing changes without impact analysis -> risk: missed verification, submission gaps.
- Skipping approvals for safety changes -> risk: noncompliance.
- No linkage to tests/requirements -> risk: lost traceability.
- Not updating SBOM after dependency changes -> risk: unmanaged vulnerabilities.
Verification Checklist
- Change request recorded with rationale and affected artifacts.
- Impact analysis completed (safety, cyber, interoperability, submission).
- Approvals obtained per policy for safety-relevant changes.
- Verification/regression defined and executed; results recorded.
- Baselines/versioning/release notes updated; traceability maintained.
- Submission impact decision documented.
Traceability
- Change IDs (
CR-###) linked to requirements, risks, commits/PRs, and test evidence. - Store decisions and approvals with release artifacts.
References
- IEC 62304 (configuration management and change control).
- FDA/MDR expectations for software change impact and documentation.
Changelog
- 1.0.0 (2026-01-04): Initial change control skill with impact analysis and approval process.
Audit History
- 2026-01-04: Audit performed. Verified:
- IEC 62304 configuration management and change control references accurate
- FDA/MDR change impact documentation expectations correctly noted